Xynomic Pharmaceuticals Holdings Inc
Xynomic Pharmaceuticals — Bison Capital Acquisition — SPAC Merger (January 2019)
33 slides from Xynomic Pharmaceuticals's SPAC merger presentation, Jan 14, 2019
Slide 1: Bison Capital Acquisition Corp. & Xynomic Pharmaceuticals, Inc. Investor Presentation
Bison Capital Acquisition Corp. & Xynomic Pharmaceuticals, Inc. Investor Presentation January 2019
Slide 2: Disclosure Disclaimer
Disclosure Disclaimer This investor presentation is not a proxy statement or a solicitation of a proxy, consent or authorization with respect to an y s ecurities or in respect of the proposed transaction. This investor presentation shall also not constitute an offer to sell or the solicitation of an
Slide 3: Why Xynomic?
Why Xynomic? 3 A pipeline of late stage and early stage innovative small molecule oncology programs Abexinostat (“ Abex ”), the lead program, in - licensed from Pharmacyclics , a subsidiary of AbbVie Inc . (“AbbVie”) » A Phase 3 HDAC inhibitor being investigated for use against lymphomas and ren
Slide 4: Transaction Overview
Transaction Overview - 1 4 • On September 12, 2018, Bison Capital Acquisition Corp. (“BCAC”) signed a definitive Merger A greement with Xynomic Pharmaceuticals, Inc. (“Xynomic”) • The merger consideration, entirely payable in BCAC shares at $10.15 per share, consists of » $350 million, subject to ce
Slide 5: Transaction Overview - 2
• BCAC will re - domesticate as a Delaware corporation prior to closing • Upon closing, BCAC will change its name to “Xynomic Pharmaceuticals Holdings, Inc.” • The board of BCAC will consist of nine directors » Four current directors of BCAC including three current independent directors » Two curren
Slide 6: Experienced Management Team
Experienced Management Team 6 Y. Mark Xu, Chairman, CEO & President Successful serial entrepreneur Pharmacyclics (General Manager, Greater China), Schering (research & development), McKesson (marketing), Bridge Lab (cofounder, China CFO) W. Jason Wu, PhD, COO More than 20 years drug developmen
Slide 7: World Class Scientific Advisory Board (SAB)
World Class Scientific Advisory Board (SAB) Dr. Pamela Munster • Professor of Medicine and Director of the Early Phase Clinical Trials Unit, University of California San Francisco • Renowned expert in solid tumor • Led cancer clinical trials for numerous big pharma and emerging biotech companies Dr.
Slide 8: Innovative Oncology Pipeline (Global Rights)
Preclinical Phase 1 Phase 2 Phase 3 Abexinostat : HDAC i nhibitor (licensor: Pharmacyclics/AbbVie) Follicular Lymphoma (4L, US, EU & China) Renal Cell Carcinoma (1L or 2L, with Novartis’ Pazopanib ) Multiple Solid Tumors (with Merck’s Keytruda ) Diffuse Large B - Cell Lymphoma & Mantel Cell Lymphoma
Slide 9: Abex: In-Licensed from Pharmacyclics/AbbVie
Abex: In - Licensed from Pharmacyclics/AbbVie 9 1. AbbVie 2015 annual report 2. Pharmacyclics December 2014 Investor Presentation 3. imbruvica.com 4. AbbVie and Johnson & Johnson 2017 annual reports Abex was previously jointly developed by Pharmacyclics world class, research and development team a
Slide 10: Abex: Overview of Clinical Development
Abex: Overview of Clinical Development 10 Already tested on approximately six hundred patients worldwide Unique PK profile HDAC inhibitor Monotherapy against » FL: 56 - 64% ORR, 625 days medium PFS » DLBCL: 34% ORR, 2.8 months medium PFS Combo: treating solid tumor based on epigenetic modi
Slide 11: Abex Mechanism of Action
Abex Mechanism of Action 11 Diverse functions of HDACs and HDAC inhibitors regulating different stages of cancer through multiple different mechanisms and changing different biological processes. Far right, ↑ indicates promotion or upregulation, ↓ indicates repression or downregulation. Source: Li a
Slide 12: Abex – Completed Clinical Trials
Abex – Completed Clinical Trials * Monotherapy In Combination Protocol # # of Patients TA Protocol # # of Patients TA PCYC - 0401 15 Solid tumors or hematological cancers CL1 - 005 35 Solid tumors PCYC - 0405 7 Hematological tumors CL1 - 006 32 Digestive cancer CL1 - 010 1 NHL CL1 - 008 19 Late stag
Slide 13: Convenient Oral Administration
Convenient Oral Administration 13 Source: Joseph J. et al. CRA - 024781: a novel synthetic inhibitor of histone deacetylase enzymes with antitumor activity in vitro and in vivo. Mol Cancer Ther; 2006: 1309 - 1317.
Slide 14: Safety
Safety Grade 3 and 4 AE% in PCYC - 0403 * Grade 3 and 4 AE% in PCYC - 1401 ** hematological Neutropenia 14 27 Anemia 7 12 Thrombocytopenia 20 80 GI Diarrhea 2 3 Vomiting 0 0 other Fatigue 3 0 Arthralgia 7 0 14 * From Abexinostat trial PCYC - 0403 (1 - week - on / 1 - week - off dosing schedule ) **
Slide 15: Abex: Objective Response Rate
Abex: Objective Response Rate FL DLBCL PTCL Assumption Phase 1 Phase 2 Assumption Phase 1 Phase 2 Assumption Phase 1 Phase 2 40% 60% 44% 56% (n=16) 20% 40% 25% 50% 23% 31% (n=16) 22% 40% (n=15) Target ORR Actual 0% 100% Source: Vincent Ribrag , et al. Safety and efficacy of abexinostat , a pan - his
Slide 16: Significantly Improved Progression-Free Survival
Significantly Improved Progression - Free Survival FL *N=25= 14 FL + 11 MCL. † Median time on study in FL is 11.9 (1.2 - 24.8) months 16 Source: Andrew M. Evens, et al. A Phase I/II Multicenter, Open - Label Study of the Oral Histone Deacetylase Inhibitor Abexinostat in Relapsed/Refractory Lymphoma.
Slide 17: PET neg in FL Patient: Complete Response
PET neg in FL Patient: Complete Response FL Case History 72 yo female 5 prior tx. Response » PR – Cycle 4 » CR - Cycle 8 Baseline 8 Cycles Abex 17 Source: Xynomic and licensor
Slide 18: Kidney Cancer: Compelling Ph 1b Data in Combination with Pazopanib
Kidney Cancer: Compelling Ph 1b Data in Treating VEGFi - Refractory Solid Tumors in Combination with Pazopanib Sponsored by NCI and UCSF Fifty one patients (72% had received two or more lines of therapy in the locally advanced or metastatic setting), Phase 1b, open - label, do se - escalation/ex
Slide 19: Abex Commercial Opportunities
Abex Commercial Opportunities Indication Global Market Size in 2023, $ Follicular Lymphoma 4.1 billion Renal Cell Carcinoma (Kidney Cancer) 4.7 billion Breast Cancer 20 billion Solid Tumors (with K eytruda) 8 billion Diffuse Large B - Cell Lymphoma 14.4 billion Sources: Decision Resources, EvaluateP
Slide 20: On-going and Planned Trials
On - going and Planned Trials Drug Indications Phase # of Patients Key Partners Location FPI Date Abex/Keytruda Multiple solid tumors 1b 42 UCSF U.S. 7/25/2018 Abex 4L FL Pivotal Ph 2 120 MSK U.S. , EU7 and China 8/ 9 /2018 Abex/Pazopanib 1L and 2L RCC Pivotal Ph 3 390 UCSF U.S., EU 6 , China and So
Slide 21: Renal Cell Carcinoma (RCC)
Renal Cell Carcinoma (RCC) Successful EOP2/Pre - Phase 3 meeting with FDA on 3/16/2018 » Authorized to start Ph 3, which potentially is pivotal » Plan to apply for Fast Track designation in Q1’2019 Ph 3 design: 1L or 2L, PFS as primary end point, Abex + Pazopanib vs. Pazopanib Well positioned
Slide 22: Follicular Lymphoma
Follicular Lymphoma r/r FL: 56 - 64% ORR and 625 days of medium PFS in two Ph 1/2 trials Successful FDA meeting on 4/18/2018 » Authorized to start Ph 2, which potentially is pivotal 4L: 120 subjects, single arm, ORR as primary end point Sites: U.S. , EU7 and China FPI: 8/ 9 /2018 U.S. in
Slide 23: China
China 3L FL potentially pivotal (independent of U.S./EU trials) » ~81 subjects, single arm, ORR as primary end point » FPI expected in Q2’2019 3L DLBCL » ~144 subjects, single arm, ORR as primary end point » FPI expected in Q2’2019 1L or 2L RCC » ~150 patients led by Prof. Jun Guo at Beijing C
Slide 24: Updated Clinical Development Timeline
Updated Clinical Development Timeline Indication Regions 2H’2018 2019 2020 2021 2022 3L FL (Abex as monotherapy) China Enroll ~55 patients Enroll ~26 patients (complete recruitment) NDA submission 4L FL (Abex as monotherapy) U.S. EU7 China Enroll ~90 patients Enroll ~30 patients (complete recruitmen
Slide 25: XP-105 (BI 860585): In-Licensed from Boehringer Ingelheim
XP - 105 (BI 860585): In - Licensed from Boehringer Ingelheim 25 • A 3rd generation, ATP competitive mTORC1/2 inhibitor against multiple solid tumors • BI has completed a Phase 1 trial on 90 subjects with advanced solid tumors • Disease control rate (complete or partial response plus stable disease)
Slide 26: Marketed mTORC Inhibitors
Marketed mTORC Inhibitors 26 • 1st generation mTORC inhibitors on the market » e verolimus ( Novartis): $1.525 billion revenue in 2017* » temsirolimus (Pfizer) » Mainly treat kidney cancer and breast cancer • Continuing strong interest in mTORC » In 2017 Celgene , Vivo and Decheng invested $23 milli
Slide 27: XP-102: A 2nd-Generation Pan-RAF Inhibitor
XP - 102: A 2nd - Generation Pan - RAF Inhibitor RAF is a popular molecular target in oncology and represents a significant commercial opportunity Two large pharmaceutical corporations namely, Roche and Novartis have already launched 1st generation oncology drugs that target RAF kinases, with pe
Slide 28: XP-102: Pre-Clinical Pharmacology Summary
XP - 102: Pre - Clinical Pharmacology Summary Demonstrated potency and selectivity in cellular and kinase assays » B - RAF V600 cell lines EC 50 <10 nM » B - RAF wild - type cell lines EC 50 >1,000 nM Strong functionality in CRC and melanoma animal models Showed no significant sign of toxicity
Slide 29: XP-102: Current Status
XP - 102: Current Status 29 API GLP toxicity batch completed All toxicology studies completed Formulation work in progress and expected to be finished by January 2019 Xynomic’s goal is to submit US - IND application in Q1’2019
Slide 30: Research Stage Programs: XP-103 & XP-104
Research Stage Programs: XP - 103 & XP - 104 (Small Molecule Kinase Inhibitors) XP - 103 » TRK/Fra - 1 inhibitor » A competitor’s TRK inhibitor Larotrectinib’s recent Ph 1 data show ORR of over 90% against multiple tumors, yet drug resistance might be an issue * » Global patent filed in December 2
Slide 31: R&D Center in Shanghai, China
R&D Center in Shanghai, China 5,600 sf custom - built, fully operational, state - of - the - art leased facility Focused on biology, organic chemistry and analytical chemistry Led by Dr. Niefang Yu, a renowned oncology research scientist Will staff up to 15 MS/PhD scientists Multiple small
Slide 32: Pipeline Summary
Pipeline Summary Abex: currently being evaluated in 3 therapeutic areas XP - 105 (BI 860585): breast cancer and CRC » 3rd generation mTORC1/2 inhibitor » Phase - 2 ready XP - 102 (BI 882370): CRC and melanoma » Animal data from initial studies suggest promising potential » Unique binding mode
Slide 33: Summary – Xynomic Pharma
Summary – Xynomic Pharma A U.S. oncology company founded by industry veterans Pure play oncology company: oral, proven molecular targets Drug candidates originated from global top - 20 pharma companies ( AbbVie and Boehringer Ingelheim ): high - quality U.S./EU data integrity, exclusive global
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